| 1. |
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| 2. |
- Berglund, Åke, et al.
(författare)
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First-in-human, phase I/IIa clinical study of the peptidase potentiated alkylator melflufen administered every three weeks to patients with advanced solid tumor malignancies
- 2015
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Ingår i: Investigational new drugs. - : Springer Science and Business Media LLC. - 0167-6997 .- 1573-0646. ; 33:6, s. 1232-1241
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Tidskriftsartikel (refereegranskat)abstract
- Purpose Melflufen (melphalan flufenamide, previously designated J1) is an optimized and targeted derivative of melphalan, hydrolyzed by aminopeptidases overexpressed in tumor cells resulting in selective release and trapping of melphalan, and enhanced activity in preclinical models. Methods This was a prospective, single-armed, open-label, first-in-human, dose-finding phase I/IIa study in 45 adult patients with advanced and progressive solid tumors without standard treatment options. Most common tumor types were ovarian carcinoma (n = 20) and non-small-cell lung cancer (NSCLC, n = 11). Results In the dose-escalating phase I part of the study, seven patients were treated with increasing fixed doses of melflufen (25-130 mg) Q3W. In the subsequent phase IIa part, 38 patients received in total 115 cycles of therapy at doses of 30-75 mg. No dose-limiting toxicities (DLTs) were observed at 25 and 50 mg; at higher doses DLTs were reversible neutropenias and thrombocytopenias, particularly evident in heavily pretreated patients, and the recommended phase II dose (RPTD) was set to 50 mg. Response Evaluation Criteria In Solid Tumors (RECIST) evaluation after 3 cycles of therapy (27 patients) showed partial response in one (ovarian cancer), and stable disease in 18 patients. One NSCLC patient received nine cycles of melflufen and progressed after 7 months of therapy. Conclusions In conclusion, melflufen can safely be given to cancer patients, and the toxicity profile was as expected for alkylating agents; RPTD is 50 mg Q3W. Reversible and manageable bone marrow suppression was identified as a DLT. Clinical activity is suggested in ovarian cancer, but modest activity in treatment of refractory NSCLC.
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| 3. |
- Carlier, Charlotte, et al.
(författare)
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Preclinical activity of melflufen (J1) in ovarian cancer
- 2016
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Ingår i: Oncotarget. - : Impact Journals, LLC. - 1949-2553. ; 7:37, s. 59322-59335
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Tidskriftsartikel (refereegranskat)abstract
- Ovarian cancer carries a significant mortality. Since symptoms tend to be minimal, the disease is often diagnosed when peritoneal metastases are already present. The standard of care in advanced ovarian cancer consists of platinum-based chemotherapy combined with cytoreductive surgery. Unfortunately, even after optimal cytoreduction and adjuvant chemotherapy, most patients with stage III disease will develop a recurrence. Intraperitoneal administration of chemotherapy is an alternative treatment for patients with localized disease. The pharmacological and physiochemical properties of melflufen, a peptidase potentiated alkylator, raised the hypothesis that this drug could be useful in ovarian cancer and particularily against peritoneal carcinomatosis. In this study the preclinical effects of melflufen were investigated in different ovarian cancer models. Melflufen was active against ovarian cancer cell lines, primary cultures of patient-derived ovarian cancer cells, and inhibited the growth of subcutaneous A2780 ovarian cancer xenografts alone and when combined with gemcitabine or liposomal doxorubicin when administered intravenously. In addition, an intra-and subperitoneal xenograft model showed activity of intraperitoneal administered melflufen for peritoneal carcinomatosis, with minimal side effects and modest systemic exposure. In conclusion, results from this study support further investigations of melflufen for the treatment of peritoneal carcinomatosis from ovarian cancer, both for intravenous and intraperitoneal administration.
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| 4. |
- Edelstam, Greta, et al.
(författare)
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Optimised gynaecological examination with a new pelvic examination chair
- 2019
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Ingår i: Sexual & Reproductive HealthCare. - : Elsevier BV. - 1877-5756 .- 1877-5764. ; 19, s. 84-87
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The present aim was to contribute to improving the traditional pelvic examination chair with vertical leg support and to evaluate patients' and examiners' experience of a new gyneacological and urological examination chair with heated upholstery.Study design: A new gynaecological and urological examination chair was constructed with laterally adjustable leg support, a foot-plate and the perineum exposed only during the examination procedure. Patients (n = 131) with or without endometriosis were invited to participate in an anonymous questionnaire survey concerning how they experienced a gynaecological examination.Main outcome measures: The patients and the gynaecologists who performed the examinations answered questionnaires evaluating the examination procedure in the traditional and in the new gynaecological and urological examination chair, respectively. The questionnaires asked about comfort, heating, integrity and the experience of pelvic examination with vertical or lateral leg support. The examination times were measured with a stopwatch.Results: The majority of the answers (n = 131) were significantly (p < 0.05-0.001) in favour of the new concept with lateral leg support and with increased comfort and integrity. The average examination time was significantly shortened and the patients more relaxed in the new gynaecological and urological examination chair.Conclusion: The traditional gynaecological chair with vertical leg support has remained basically unchanged for many years. The present study showed that the pelvic examination procedure can be significantly optimized with easy patient-friendly adaptations.
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| 5. |
- Edelstam, Greta, et al.
(författare)
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Pertubation with lidocaine - a non-hormonal, long-term treatment of dysmenorrhea due to endometriosis
- 2012
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Ingår i: Sexual & Reproductive HealthCare. - : Elsevier. - 1877-5756 .- 1877-5764. ; 3:2, s. 93-94
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Tidskriftsartikel (refereegranskat)abstract
- The major symptoms of endometriosis are dysmenorrhea and infertility. Pertubations with lidocaine have been shown to reduce dysmenorrhea and have an enhancing effect on fertility. Different concentrations of lidocaine were evaluated in a randomized, double-blind study of pre-ovulatory pertubations with lidocaine solutions in women with dysmenorrhea. The patients had laparoscopically diagnosed endometriosis and normal fallopian tubes. Ninety pertubations were carried out without complications on 26 patients during up to six cycles. The effect was evaluated by means of questionnaires where a clinically significant reduction of dysmenorrhea was reported. Pertubation with lidocaine can be a non-hormonal treatment option for dysmenorrhea. (C) 2012 Elsevier B.V. All rights reserved.
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| 6. |
- Johansson, Dongni, 1988, et al.
(författare)
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Individualization of levodopa treatment using a microtablet dispenser and ambulatory accelerometry
- 2018
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Ingår i: CNS Neuroscience & Therapeutics. - : Wiley. - 1755-5930 .- 1755-5949. ; 24:5, s. 439-447
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Tidskriftsartikel (refereegranskat)abstract
- Aim: This 4-week open-label observational study describes the effect of introducing a microtablet dose dispenser and adjusting doses based on objective free-living motor symptom monitoring in individuals with Parkinson's disease (PD). Methods: Twenty-eight outpatients with PD on stable levodopa treatment with dose intervals of ≤4 hour had their daytime doses of levodopa replaced with levodopa/carbidopa microtablets, 5/1.25 mg (LC-5) delivered from a dose dispenser device with programmable reminders. After 2 weeks, doses were adjusted based on ambulatory accelerometry and clinical monitoring. Results: Twenty-four participants completed the study per protocol. The daily levodopa dose was increased by 15% (112 mg, P < 0.001) from period 1 to 2, and the dose interval was reduced by 12% (22 minutes, P = 0.003). The treatment adherence to LC-5 was high in both periods. The MDS-UPDRS parts II and III, disease-specific quality of life (PDQ-8), wearing-off symptoms (WOQ-19), and nonmotor symptoms (NMS Quest) improved after dose titration, but the generic quality-of-life measure EQ-5D-5L did not. Blinded expert evaluation of accelerometry results demonstrated improvement in 60% of subjects and worsening in 25%. Conclusions: The introduction of a levodopa microtablet dispenser and accelerometry aided dose adjustments improve PD symptoms and quality of life in the short term.
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| 7. |
- Lu, Yingchang, et al.
(författare)
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New loci for body fat percentage reveal link between adiposity and cardiometabolic disease risk
- 2016
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Ingår i: Nature Communications. - : Springer Science and Business Media LLC. - 2041-1723. ; 7
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Tidskriftsartikel (refereegranskat)abstract
- To increase our understanding of the genetic basis of adiposity and its links to cardiometabolic disease risk, we conducted a genome-wide association meta-analysis of body fat percentage (BF%) in up to 100,716 individuals. Twelve loci reached genome-wide significance (P<5 × 10(-8)), of which eight were previously associated with increased overall adiposity (BMI, BF%) and four (in or near COBLL1/GRB14, IGF2BP1, PLA2G6, CRTC1) were novel associations with BF%. Seven loci showed a larger effect on BF% than on BMI, suggestive of a primary association with adiposity, while five loci showed larger effects on BMI than on BF%, suggesting association with both fat and lean mass. In particular, the loci more strongly associated with BF% showed distinct cross-phenotype association signatures with a range of cardiometabolic traits revealing new insights in the link between adiposity and disease risk.
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| 8. |
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| 9. |
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| 10. |
- Memedi, Mevludin, 1983-, et al.
(författare)
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Construction of levodopa-response index from wearable sensors for quantifying Parkinson's disease motor functions
- 2016
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- The goal of this study was to investigate the feasibility of wrist worn motion sensors to objectively measure motor functions in Parkinson’s disease (PD). More specifically, the aim was to construct a sensor-based levodopa-response index (SBLRI) and evaluate its clinimetric properties (convergent validity and internal consistency). Nineteen advanced PD patients and 22 healthy controls were recruited in a single center, open label, single dose clinical trial in Sweden. The subjects performed standardized motor tasks while wearing one sensor on each wrist and one on each ankle. Each sensor unit consisted of three-dimensional accelerometer and gyroscope. The patients were video recorded and the videos were blindly rated by three independent movement disorder specialists. The clinical scores were given using the Treatment Response Scale (TRS) on a scale from -3 = ‘Very Off’ to 0 = ‘On’ to +3 = ‘Very dyskinetic’. The clinical assessments were based on the overall motor function of the patients. A mean TRS was defined as the mean of the three specialists’ assessments per time point. The measurements were repeated over several time points following a single levodopa/carbidopa morning dose (50% over normal to induce dyskinesias). Sensor measurements during rapid alternating movements of hands were processed with time series analysis methods to calculate spatiotemporal parameters designed to measure bradykinesia and dyskinesia. For each hand, 96 spatiotemporal parameters were calculated and their average scores were then used in a principal component analysis to reduce the dimensionality by retaining 6 principal components. These components were then used as predictors to support vector machines and to be mapped to the mean TRS ratings of the three specialists and to calculate the SBLRI. For this analysis, a 10-fold stratified cross-validation was performed. The SBLRI was strongly correlated to mean TRS with a Pearson correlation coefficient of 0.79 (CI: 0.74-0.83, p<0.001). The 95% confidence interval for the mean squared error of SBLRI on patients data was ± 1.62 with a mean value of 0.57 whereas on healthy controls data was ± 1 with a mean value of 0.27. The sensor-based spatiotemporal parameters had good internal consistency with a Cronbach’s Alpha coefficient of 0.87 and significantly differed between patients and healthy controls. The results demonstrated that the SBLRI had good clinimetric properties for measuring motor functions (Off and dyskinesia) in PD patients. The method could also distinguish hand rotation movements exhibited by patients from those exhibited by healthy controls. The SBLRI provides effect-time profiles, which could be useful during therapy individualization of advanced PD patients.
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| 11. |
- Memedi, Mevludin, PhD, 1983-, et al.
(författare)
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Sensor-based Measurement of Nociceptive Pain : An Exploratory Study with Healthy Subjects
- 2022
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Ingår i: Pervasive Computing Technologies for Healthcare. - Cham : Springer. - 9783030991937 - 9783030991944 ; , s. 88-95
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Konferensbidrag (refereegranskat)abstract
- Valid assessment of pain is essential in daily clinical practice to enhance the quality of care for the patients and to avoid the risk of addiction to strong analgesics. The aim of this paper is to find a method for objective and quantitative evaluation of pain using multiple physiological markers. Data was obtained from healthy volunteers exposed to thermal and ischemic stimuli. Twelve subjects were recruited and their physiological data including skin conductance, heart rate, and skin temperature were collected via a wrist-worn sensor together with their selfreported pain on a visual analogue scale (VAS). Statistically significant differences (p< 0.01) were found between physiological scores obtained with the wearable sensor before and during the thermal test. Test-retest reliability of sensor-based measures was good during the thermal test with intraclass correlation coefficients ranging from 0.22 to 0.89. These results support the idea that a multi-sensor wearable device can objectively measure physiological reactions in the subjects due to experimentally induced pain, which could be used for daily clinical practice and as an endpoint in clinical studies. Nevertheless, the results indicate a need for further investigation of the method in real-life pain settings.
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| 12. |
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| 13. |
- Senek, Marina, et al.
(författare)
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Levodopa/carbidopa microtablets in Parkinson disease : pharmacokinetics and blinded motor assessment
- 2016
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Ingår i: Twentieth International Congress of Parkinson's Disease and Movement Disorders.
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- The aim of this study was to characterize the levodopa and carbidopa plasma concentration in relation to blinded motor function ratings. This is a part of a study where a Multimodal motor Symptoms Quantification (MuSyQ) platform consisting of three different types of sensors were tested while evoking motor fluctuations with levodopa/carbidopa(LD/CD) microtablets in fluctuating Parkinson’s disease (PD) patients. Today, dose titration and chronic treatment largely relies on the patient’s subjective assessment of symptoms and clinicians’ assessment of patient status during a visit at the clinic. This was a single-center, open-label, single dose study in patients experiencing motor fluctuations. Patients were given 150% of their individual levodopa equivalent morning dose. Blood sampling and motor function testing were conducted for up to 6.5 hours at prespecified time points. The patients performed standardized motor activities for clinical rating in accordance with parts of the Unified Parkinson’s disease Rating Scale (UPDRS) and Unified Dyskinesia RatingScale (UDysRS). Each test cycle was video recorded, and the video sequences were presented to three movement disorder specialists in a randomized order for blinded rating of UPDRS items and the treatment response scale (TRS). Concentration versus time profiles and the pharmacokinetics were compared with a study previously conducted in healthy subjects. Nineteen patients, 14 male and 5 female, were included in the study. The individual LD/CD doses ranged between 110/27.5mg to 410/102.5 mg. The concentration time profiles are similar to the LD/CD microtablet profiles reported in healthy subjects. The blinded video ratings managed to capture the most distinctive movements. This is the first pharmacokinetic study where patients received LD/CD microtablets. For patients fluctuating from 'off' to dyskinetic, the relationship between the plasma concentration and motor function was clearer compared to the patients that fluctuated to a lesser extent.
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| 14. |
- Senek, Marina, et al.
(författare)
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Levodopa/carbidopa microtablets in Parkinson's disease : a study of pharmacokinetics and blinded motor assessment
- 2017
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Ingår i: European Journal of Clinical Pharmacology. - Heidelberg, Germany : Springer. - 0031-6970 .- 1432-1041 .- 0014-2999. ; 73:5, s. 563-571
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Tidskriftsartikel (refereegranskat)abstract
- Background: Motor function assessments with rating scales in relation to the pharmacokinetics of levodopa may increase the understanding of how to individualize and fine-tune treatments.Objectives: This study aimed to investigate the pharmacokinetic profiles of levodopa-carbidopa and the motor function following a single-dose microtablet administration in Parkinson’s disease.Methods: This was a single-center, open-label, single-dose study in 19 patients experiencing motor fluctuations. Patients received 150% of their individual levodopa equivalent morning dose in levodopa-carbidopa microtablets. Blood samples were collected at pre-specified time points. Patients were video recorded and motor function was assessed with six UPDRS part III motor items, dyskinesia score, and the treatment response scale (TRS), rated by three blinded movement disorder specialists.Results: AUC0–4/dose and Cmax/dose for levodopa was found to be higher in Parkinson’s disease patients compared with healthy subjects from a previous study, (p = 0.0008 and p = 0.026, respectively). The mean time to maximum improvement in sum of six UPDRS items score was 78 min (±59) (n = 16), and the mean time to TRS score maximum effect was 54 min (±51) (n = 15). Mean time to onset of dyskinesia was 41 min (±38) (n = 13).Conclusions: In the PD population, following levodopa/carbidopa microtablet administration in fasting state, the Cmax and AUC0–4/dose were found to be higher compared with results from a previous study in young, healthy subjects. A large between subject variability in response and duration of effect was observed, highlighting the importance of a continuous and individual assessment of motor function in order to optimize treatment effect.
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| 15. |
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| 16. |
- Senek, Marina, et al.
(författare)
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Motor fluctuations in relation to plasma concentrations following a single-dose of levodopa/carbidopa microtablets in advanced Parkinson's disease
- 2016
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Objective: The aim of this study was to characterize the levodopa and carbidopa plasma concentration in relation to blinded motor function ratings. This is a part of a study where a Multimodal motor Symptoms Quantification (MuSyQ) platform consisting of three different types of sensors were tested while evoking motor fluctuations with levodopa/car-bidopa (LD/CD) microtablets in fluctuating Parkinson’s disease (PD) patients.Background: Today, dose titration and chronic treatment largely relies on the patient’s subjective assessment of symptoms and clinicians’ assessment of patient status during a visit at the clinic.Methods: This was a single-center, open-label, single dose study in patients experiencing motor fluctuations. Patients were given 150% of their individual levodopa equivalent morning dose. Blood sampling and motor function testing were conducted for up to 6.5 hours at prepecified time points. The patients performed standardized motor activities for clinical rating in accordance with parts of the Unified Parkinson’s disease Rating Scale (UPDRS) and Unified Dyskinesia Rating Scale (UDysRS). Each test cycle was video recorded, and the video sequences were presented to three movement disorder specialists in a randomized order for blinded rating of UPDRS items and the treatment response scale (TRS). Concentration versus time profiles and the pharmacokinetics were compared with a study previously conducted in healthy subjects.Results: Nineteen patients, 14 male and 5 female, were included in the study. The individual LD/CD doses ranged between 110/27.5 mg to 410/102.5 mg. The concentration time profiles are similar to the LD/CD microtablet profiles reported in healthy subjects. The blinded video ratings managed to capture the most distinctive movements.Conclusions: This is the first pharmacokinetic study where patients received LD/CD microtablets. For patients fluctuating from ‘off’ to dyskinetic, the relationship between the plasma concentration and motor function was clearer compared to the patients that fluctuated to a lesser extent.
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| 17. |
- Somayeh, Aghanavesi, et al.
(författare)
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Quantification of upper limb motor symptoms of Parkinson's disease using a smartphone
- 2016
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Objective: The aim of this study is to develop and evaluate methods for quantifying motor symptoms in Parkinson’s disease (PD) using combined upper limb motor test data collected during tapping and spiral drawing tasks by a smart phone.Background: PD is a multidimensional and complex disorder affecting motor and non motor functionalities. Assessments of PD symptoms are usually done by clinical rating scales. One of them is the Unified PD Rating Scale (UPDRS) developed to provide comprehensive, efficient and flexible means to monitor PD-related disability and impairments. It has been the most commonly used rating scale. It is composed of four main parts where the third part is designed for rating of motor symptoms. However, UPDRS has relatively poor inter-rater reliability. Another scale that is used to grade motor function of patients is Treatment Response Scale (TRS). A limitation is that there is no general agreement on which parts of the symptomatology should be included in the TRS score. However, the scales have low intra- and inter-rater reliability and their use is limited, as they are only used during in-clinic observations.Methods: Participants: Nine-teen patients diagnosed with PD and 22 healthy controls were recruited in a single center, open label, single dose clinical observational study in Sweden. Simultaneous clinical- and smartphone-based measures were collected up to 15 times following a single levodopa/carbidopa morning dose (50% over normal to induce dyskinesias).Clinical assessment: Subjects were asked to perform standardized motor tests in accordance with UPDRS and were videotaped. The videos were blindly rated by three movement disorder specialists. The ratings were given based on TRS ranging from -3, 'Very Off' to 0, 'On' to +3, 'Very dyskinetic', three UPDRS motor items (item 23, finger taps; item 25, rapid alternating movements of hands, item 31, body bradykinesia and hypokinesia) and dyskinesia score. Means of the three specialists' assessments per time point on these scales were used in subsequent analysis.Smartphone-based data collection: On each test occasion, the subjects performed upper limb motor tests (tapping and spiral drawings) using a smartphone. The subjects were instructed to perform the tests using an ergonomic pen stylus with the device placed on a table and to be seated in a chair. During tapping tests, the subjects were asked to alternately tap two fields (as shown in the screen of the device) as fast and accurate as possible, using first right hand and then left hand. Each tapping test lasted for 20 seconds. During spiral tests, the subjects were instructed to trace a pre-drawn Archimedes spiral as fast and accurate as possible, using the dominant hand. The spiral test was repeated three times per test occasion. The smartphone recorded both position and time-stamps (in milliseconds) of the pen tip.Data processing and analysis: The raw tapping and spiral data were processed with time series analysis methods, including both time- and frequency-domains methods. Nineteen and 22 spatiotemporal features were extracted from spiral and tapping data, respectively. Features were calculated to represent various kinematic quantities during the motor tests such as acceleration, speed, time delay, and distance. The features from both tapping and spiral data were used in a Principal Component Analysis and 7 principal components (PCs) were retained, which in turn were used as inputs to a Support Vector Machines (SVM) to be mapped to mean clinical ratings. The analyses were performed with a stratified 10-fold cross-validation. Test-retest reliability of the spiral tests were assessed after calculating correlations between the first PCs for the three spiral tests and then calculating the mean of all possible correlations.Results: The correlation coefficients between SVM predictions and mean clinical ratings were as follows: 0.59 for TRS, 0.6 for dyskinesia score, 0.52 for item 23 of UPDRS (finger taps), 0.47 for item 25 of UPDRS (rapid alternating movements of hands), and 0.57 for item 31 of UPDRS (body Bradykinesia and Hypokinesia). The spiral test had a good test-retest reliability with a coefficient of 0.84, indicating that spiral scores are stable and consistent over time. When assessing the ability of the PCs to distinguish between patients and healthy controls the means of 3 out of 7 PCs (PC1, PC2 and PC4) were different between the two groups (p<0.005).Conclusions: The upper limb motor tests of the smartphone were able to capture important and relevant symptom information of the clinical rating scales. The methods for quantifying the upper limb motor symptoms of PD patients: had adequate correlations to clinical ratings were able to differentiate between movements of patients and healthy controls, and(Spiral tests) had good test-retest reliability.
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| 18. |
- Thomas, Ilias, et al.
(författare)
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Systems for evaluating dosage parameters
- 2018
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Patent (populärvet., debatt m.m.)abstract
- A system comprising a prescription-determination-module that is configured to: receive patient-model-data, wherein the patient-model-data comprises one or more dose-effect- parameters that represent how a patient is expected to react to a dose of medicament over time; apply a plurality of different dosage-parameters to the patient-model-data, in order to determine a plurality of dosage-effect-data; apply one or more selection-criteria to the plurality of dosage-effect-data in order to determine one or more of the associated dosage- parameters as selected-dosage-parameters; and provide an output-signal based on the selected-dosage-parameters.
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| 19. |
- Wickstrom, Karin, et al.
(författare)
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Quality of life in patients with endometriosis and the effect of pertubation with lidocaine - a randomized controlled trial
- 2013
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 92:12, s. 1375-1382
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Tidskriftsartikel (refereegranskat)abstract
- ObjectivePertubation with lidocaine has been shown to reduce pain (on a VAS-scale) in women with endometriosis. A clinical study was performed to evaluate the effect of lidocaine pertubations on quality of life. DesignDouble-blind, randomized and controlled trial. SettingThree outpatient units in Stockholm, Sweden. PopulationEligible patients had endometriosis with dysmenorrhoic pain >VAS 50mm. MethodsThe patients were randomized to pre-ovulatory pertubations with lidocaine (n=24) or placebo (n=18) during three consecutive menstrual cycles. The procedure comprised passing the solution through the uterus and the Fallopian tubes via an intracervical balloon catheter. The effect was evaluated with the validated Endometriosis Health Profile-30 questionnaire before and after treatments. Main outcome measuresChanges in scores at six and 12 months from baseline were compared between the groups with the Mann-Whitney U-test. ResultsAfter 6months there was a significant difference between the lidocaine (n=19) and the placebo (n=16) groups for the dimension social support (median -18.8 vs. -6.3, p=0.034), whereas there were no significant differences for the other dimensions after 6 or 12months. The mean changes in the lidocaine group were above the minimal important difference levels in eight of 12 measurements of quality of life dimensions compared with two of 12 in the placebo group. ConclusionsThis clinical trial indicates that pertubations with lidocaine might improve the social support dimension of quality of life in patients with endometriosis.
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